US FDA approves new opto-acoustic imaging for breast lesions

US FDA approves new opto-acoustic imaging for breast lesions

A Texas-based firm, Seno Medical has recently received the US FDA approval for its new opto-acoustic imaging device named Imagio that could help physicians identify whether breast lesions are benign or malignant. According to the company, this non-invasive and radiation-free technology will help to reduce the number of biopsies that have to be performed.

Imagio uses opto-acoustic (OA) imaging that combines light (laser optics) and ultra sound (US) waves that could provide more information to quickly and accurately diagnose suspicious mammogram results.

Cancerous lesions commonly exhibit angiogenesis resulting in a high density of newly formed blood vessels and a lower oxygen saturation compared with surrounding tissues. The system provides a combined view of tissue anatomy and the blood flow around it. With the help of accompanying AI software called SenoGram, the device can help differentiate malignant and benign breast lesions in many cases.

Optimizing the diagnosis of breast masses requires a combination of very high sensitivity (≥98%) while simultaneously maximizing specificity and minimizing false positives and biopsies of benign masses, said Dr Tom Stavros, Seno’s Chief Medical Officer, in a statement.

“The data from the premarket approval study (PMA) shows that OA/US successfully achieved improved specificity at a fixed sensitivity of 98%, the part of the ROC curve where clinical decisions about whether or not to biopsy a mass are actually made.” said Dr Stavros.